Carol Head Addresses the IOM Committee

On Monday, January 27th, 2014, Carol Head, Association President and CEO was in Washington D.C. along with several other organization leaders, fellow advocates and patients to take part in the first public meeting of the IOM Committee for Diagnostic Criteria for ME/CFS. The transcript of her full comment is below, as well as a link to the full report created from the “Road to Diagnosis” survey we conducted.

Stay up to date on the activities of the committee and see the full broadcast (once posted) HERE

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Hello and thank you for the time here today. I’m Carol Head, President and CEO of the Solve ME/CFS Initiative . The mission of the Solve ME/CFS Initiative is to make ME/CFS understood, diagnosable and treatable. We’re primarily a research organization – we fund research aimed at the early detection, objective diagnosis and effective treatment of ME/CFS We do that by pulling together public and private funds and dispersing it to the best ME/CFS researchers. We were pleased to work with the “Let’s Get It Right” group to prepare for this meeting.

Our involvement in this IOM process stems from our desire to inform the regulatory framework and to accelerate approval of ME/CFS therapies. The development of safe and effective treatments for ME/CFSrequires strengthened,uniformly-accepted criteria that can be used consistently by researchers, clinicians and patients. The lack of uniformly-accepted clinical diagnostic criteria is one of many reasons for the slow progress against this illness.

The FDA has stated that, “When there is confusion, lack of consensus & no progress, go back the Core”. The “core” regulatory framework for any disease is: core signs, symptoms or decreases in specific functioning. The FDA recognizes that for ME/CFS, we are still at the very beginning of understanding the core.

We applaud HHS’s effort to address this critically important issue. And at the same time, we anticipate that your work will be extremely difficult, despite your best efforts, as the available research is more limited than any of us would want.

Despite disagreement about the best way forward, we all acknowledge the need for evidence-based, broadly-accepted clinical and research tools that can accurately include or identify all subsets of the heterogeneous group that presents under any of the case definitions of ME/CFS. We believe that the Canadian Consensus Criteria can be optimized as a clinical case definition by applying a standardized methodology, validation of criteria, and nationwide dissemination to health professionals.

We all understand the desperate urgency of the situation – It is imperative that the patient’s journey to diagnosis and treatment be faster and easier – for both the patient and the physician. Our next slides, which document the patient experience, make that painfully clear.

This month, the Solve ME/CFS Initiative conducted a survey to understand the patients’ journey with ME/CFS. Of the 256 people who responded, 88% have been diagnosed with ME/CFS by a physician. 32% indicated it took 1 year or less to get a diagnosis, while 36% said it took between 1-5 years, 21% stated it took 5-10 years and nearly 12% waited more than 10 years to be diagnosed. This is a desperately long time to live with pain and impairment, without validation.

The majority of patients saw more than 4 doctors to get that ME/CFS diagnosis. This implies time lost, quality of life lost, demoralization and precious dollars spent. Further, the longer it takes to get a diagnosis, the worse a patient gets and becomes more difficult to treat. One of this panel’s charges – to develop good diagnostic criteria into the hands of all physicians is imperative to faster diagnosis and, therefore, better care.

Over and over again, patients told us stories of delayed diagnosis, lack of treatment, a need to educate the doctor, increased disability and even hostility due to physician lack of knowledge and empathy. Patients spoke of the unfortunate ignorance of some in the medical community.

Some patient quotes:

“I have searched and searched in my area and cannot find anyone who knows anything. At first I read as much as I could about ME/CFS… but eventually, the whole process got too exhausting. I feel that the medical world has failed me… I’ve pretty much given up hope.”

“Even though I’ve been diagnosed by a healthcare professional, I’ve had other healthcare professionals question the diagnosis, express to me that they don’t believe it exists and don’t appear to understand it.”

“I saw one of the best diagnosticians in the area (with an incredible reputation), and he was not able to recognize that the symptoms I was describing fit under the ME/CFS umbrella, and in fact are very common with that illness.”

“It is up to me to teach the GP about the condition. That is, the patient has to tell the GPs that the symptoms points towards ME. If I didn’t have knowledge of the existence of ME, I might not have the possibility to get diagnosed.”

“I have been told that the recovery of my ability to function was greatly hindered by the lengthy time of being undiagnosed or treated”

And at the same time that it’s imperative to develop and disseminate a consistent diagnostic criteria, we know that time has not stood still. The few clinicians who specialize in ME/CFS have developed solid intuition and are now treating a few patients to mitigate their symptoms in some cases. This is far from a cure and the situation is not ideal, but treatment is occurring and should not be ignored.

Wanting to better understand ME/CFS clinicians’ intuition, in 2012 we conducted a survey asking 25 physicians – all ME/CFS experts – how they treated their patients’ symptoms. This chart shows some of the Solve ME/CFS Initiative’s survey results. The horizontal axis lists symptoms, the vertical-axis is the effectiveness of the drugs used to treat each symptom. Each dot represents a drug that was identified by 5 or more clinicians as having a positive effect.

So we see that there are a number of drugs used by physicians that effectively treat symptoms. We show this data to illustrate that diagnosis, management and treatment of ME/CFS, while woefully inadequate, is possible even now, for those few patients who find and can afford an ME/CFS expert.

Several physicians surveyed were involved in drafting some of the diagnostic criteria in use today. Good clinical diagnostic criteria in the hands of all physicians will allow this result to scale, reaching more patients.

And going even further. Good clinical diagnostic criteria will lead to biomarker discovery. This slide is the result of research funded by our organization that’s being prepared for publication. Blood samples from our SolveCFS BioBank were used in this research; the samples were selected using the Canadian Consensus Criteria. The horizontal axis shows 100 different genes and the vertical axis shows whether the sample was from an ME/CFS patient or a control. We’ve drawn a horizontal line to help delineate where the pattern changes. Look at the pattern of the green color. As you can see, the majority of ME/CFS patients above the line are distinct from the majority of the controls below. It’s noteworthy that these samples came from patients being cared for by expert ME/CFS physicians – who use current clinical definitions and diagnostic criteria – again demonstrating that clinical diagnostic criteria is possible for ME/CFS.

The credibility and authority of this IOM committee is important to making ME/CFS widely recognized and diagnosed throughout our nation’s medical community. And that will help the one million Americans who struggle with this serious illness. The success of this committee is of great importance; you have an unprecedented opportunity in the history of ME/CFS.

Thank you for this opportunity to convey the Solve ME/CFS Initiative’s research-driven insights and perspectives.

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The committee asked for continued feedback from the patient community, especially as it pertains to the disease name. Comments can be directed to: mecfs@nas.edu

Thank you for sharing this information. I have been ill with ME/CFS for almost18 years. I participated in the survey & it was interesting to see the results. I have been mostly bedridden/housebound from my last relapse which has been a torturous two years long. Still fighting for Disability Insurance. Sick, broke, unable to live an independent life.

Justin Reilly

So the CAA BioBank is now using CCC? Which is what patients have been pushing for and CAA resisting. Pls give details (such as when this started and whether now all samples only taken from CCC patients). Thanks.

To provide crucial context you might have added that HHS, you (CAA) and the Wessley school are the reasons why ME has been criminally neglected and the science intentionally distorted.

Emma

Thank you for publishing this. I was a little surprised that the comment seems to mainly focus on the need for a good-quality and well-disseminated clinical definition rather than on what the IOM panel needs to know to get the definition right. Would we need to use every opportunity to inform the panel on the possible pitfalls and point them in the right (biomedical) direction?